Epiretinal Membrane, Macular Hole, Retinal Detachment, Vitrectomy, Vitreous Hemorrhage
Conditions
Brief summary
This prospective randomised controlled trial will be conducted to investigate that increasing the vitrectomy cutting rate from 10,000 cut/min to 20,000 cut/min will result more efficiency and shorter core vitrectomy time, and it is equally safe as compared to the current 10,000 cut/min. We plan to target the patients undergoing for vitrectomy for common vitreoretinal pathology. Our plan is to conduct a randomised study with 2 arms, one with the higher cutting rate (20,000 cut/min) versus a second arm using the existing system 10,000 cuts/min.
Detailed description
In addition, we will measure the core vitrectomy duration by Constellation Vision System stopwatch. We will count the duration when the vitrectomy probe enter into the eye to the moment the performing the air/fluid exchange by shaving the peripheral vitreous to complete the vitrectomy. For our second outcome measure to prove the no-inferiority of intraoperative and postoperative complications patients will have 3 months follow up visits.
Interventions
DEVICE25 gauge 20,000 cpm Hypervit Dual Blade
Vitrectomy blade with increased cutting rate to 20,000 cut/min
DEVICE25 gauge 10,000 cpm Ultravit Vitrectomy Cutter
Existing Vitrectomy blade with cutting rate 10,000 cut/min
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients are randomised and masked from the treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient over 18 years of age who are undergoing vitrectomy for the following conditions: * Macular hole * Epimacular membrane * Vitreous hemorrhage * Primary retinal detachment
Exclusion criteria
* Patient who is * unable to give proper consent * previous vitrectomy or scleral buckle surgery * cases requiring silicone oil tamponed * undergoing repeated retinal detachment surgery * undergoing surgery for tractional diabetic retinopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Core vitrectomy | intraoperative (From the moment probe enter into the eye till performing the air/fluid exchange to complete the vitrectomy) | Measurement of core vitrectomy duration by Constellation Vision System |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-inferiority of intraoperative and postoperative complication | 3 months | Safety and Efficacy |
Countries
Hong Kong
Outcome results
None listed